Sonoma Fifth Metatarsal Repair System— 510(k) K161371
Substantially EquivalentSonoma Orthopedic Products, Inc.
FDA 510(k) clearance K161371 for Sonoma Fifth Metatarsal Repair System, Substantially Equivalent on 2017-02-24. Applicant: Sonoma Orthopedic Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonoma Orthopedic Products, Inc.
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo Grove, IL, US
Recent devices under product code HSB
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Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.